Irwin, M.R., Olmstead, R., Carrillo, C., Sadeghi, N., Nicassio, P., Ganz, P.A., & Bower, J.E. (2017). Tai chi chih compared with cognitive behavioral therapy for the treatment of insomnia in survivors of breast cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 35, 2656–2665.

The purpose was to examine whether tai chi chih (TCC) is noninferior in effect to cognitive behavioral therapy (CBT-I) in reducing insomnia in breast cancer survivors.

Participants were randomly assigned to two groups: those receiving CBT-I and those receiving TCC. Prior to the intervention, participants were enrolled in a 2-month phase-in period to establish their degree of insomnia. CBT-I and TCC groups were comprised of 7-10 participants and consisted of weekly 120-minute sessions. Interventions were held over two months, with a third month of skill consolidation and adherence (three months total intervention exposure). Remission of insomnia was also measured by an interviewer blinded to intervention exposure who evaluated remission according to DSM-IV-TR criteria. Assessments  of insomnia, a daily sleep diary, polysomnography levels, levels of fatigue, sleepiness, depressive symptoms, body mass index, and physical activity levels were collected at month 2 (baseline data), month 3 (post intervention), and follow-up assessments at months 6 and 15.

• N: 90   
• AGE: Range = 42-83 years, Mean = 59.6
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors met the DSM-IV-TR criteria for insomnia had reported sleep difficulties at least 3 times or more per week for at least three months or more; had finished surgical, radiation, or chemotherapy treatment at least 6 months prior; and did not have recurrence of cancer or a new tumor.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Los Angeles, CA

PHASE OF CARE: Late effects and survivorship

Two groups were established in a randomized, partially blinded, noninferiority trial. Participants were blinded to the hypothesis and the alternate treatment group.

• Sleep quality was measured using the Pittsburgh Sleep Quality Index and Athens Insomnia Severity Index. 
• Objective sleep continuity was measured using polysomnography and subjectively with sleep diaries. 
• For secondary outcomes, insomnia remission was evaluated using DSM-IV-TR criteria and reviewed utilizing board-certified psychiatrists and psychologists. Fatigue was measured using the Multidimensional Fatigue Symptom Inventory, sleepiness was measured using the Epworth Sleepiness Scale, and depressive symptoms were measured using the Inventory of Depressive Symptoms. Body mass index and physical activity levels (Yale Physical Activity Survey) were also measured. A noninferiority margin of 50% was used.

Responsiveness to CBT-I or TCC treatment was comparable with a responsiveness rate of 43.6% and 46.7%, respectively. The noninferiority margin for this study’s purposes was set at 50%, and noninferiority of TCC was observed at month 3 (p = 0.02), month 6 (p =< 0.01), and month 15 (p = 0.02). Both treatments resulted in comparable insomnia remission rates at month 15 (46.2% and 37.9%, respectively). Differences in change of PSQI or AISI, as well as change in sleep time and wake after sleep onset, and effects on fatigue, sleepiness, or depression from baseline were not significant in comparing treatment groups (p > 0.3, p > 0.4, p > 0.5, respectively). PSG did not demonstrate treatment effects or differences across groups of significance.

CBT-I and TCC demonstrated high patient responsiveness and sustainable insomnia reduction at follow up yet yielded nonsignificant differences between treatment groups, thereby demonstrating noninferiority of TCC to CBT-I. Improvements in sleep quality, fatigue, sleepiness, and depressive symptoms were observed among both groups, but group differences were again not significant.

• Small sample (< 100)
• Findings were not generalizable.
• Intervention was expensive and impractical, and training was needed.
• Subject withdrawals ≥ 10%

Given not only the prevalence, but debilitative effect insomnia has on patients with cancer, alternative treatments to CBT-I, such as TCC, are important for nurses to assess and identify for patients, who may have variances in access to clinical CBT-I treatment.